Kornimate/medical-research-clean huggingface dataset:
advanced endo-therapeutic procedure : registry-based observational study

Conditions: Zenker Diverticulum; Polyp of Colon; Colo-rectal Cancer

Summary: advanced therapeutic endoscopy procedures are of increasing importance to provide minimal invasive treatment for gi diseases. the centre hospitalier de l'université de montréal as tertiary university center is dedicated to increase the availability of therapeutic endoscopy procedures for our population in montreal and quebec. advanced endotherapeutic endoscopy can replace surgery for treatment of benign and malign gi diseases and the aim of this registry-based study is to improve quality related to advanced endotherapeutic endoscopy, as it will provide quantitative means to assess advanced endotherapeutic practice and may identify practices of low quality (possible intervention) or high quality (desired).

advanced therapeutic endoscopy procedures included for this registry-based study are endoscopic mucosal resection (emr), endoscopic mucosal dissection (esd), assessment of polypectomy quality for colorectal adenomas/polyps, radio frequency ablation (rfa) and argon plasma ablation (apc), and per oral endoscopic myotomy (poem). all patients who present for an advanced endotherapeutic endoscopy (esd, emr, deep resection, poem or zenker treatment) may be included into the registry. data will be collected prospectively. data will be recorded on case report forms (crf), which will then be transferred to an electronic data base (= registry), located on a protected drive.

Eligibility criteria:
inclusion criteria: * age \>18 years * presenting for an elective advanced therapeutic endoscopy (esd, emr, advanced polypectomy, poem or zenker treatment) * signed informed consent form exclusion criteria: * patients that are not capable understanding the trial and patients without consent. * patients with coagulopathy * patient with poor general health defined as an american society of anesthesiologists class greater than three * pregnancy
study 3 learning verbs and pronouns

Conditions: Autism Spectrum Disorder

Summary: the goal of this research is to explore abilities to learn word meanings from overheard speech in children with asd (and, as a control, typically developing children). specific aim 3 (experiment 3): determine whether children with asd can learn verbs and pronouns by overhearing. most prior work on learning from overheard speech has focused on learning nouns that label objects. this experiment extends this work to study other kinds of words.


Eligibility criteria:
inclusion criteria: \* children with or without a diagnosis of asd between 24 to 71 months of age exclusion criteria: * native language is not english * born premature (\< 36 weeks) * has uncorrected hearing or vision impairments * has developmental disorders or medical conditions other than asd that affect language or cognition (excepting psychiatric conditions often comorbid with asd such as adhd) * has a history of photosensitive epileptic seizures
effect of prescribed cardiac rehabilitation in patients with advanced heart failure or ventricular assist device

Conditions: Heart Failure

Summary: this trial will evaluate the effect of prescribed exercise training on quality of life and exercise capacity of patients with advanced heart failure or after ventricular assist device implantation. furthermore, clinical, laboratory and echocardiographic markers of heart failure, rehospitalization rates and cost-effectiveness will be assessed.


Eligibility criteria:
inclusion criteria: * age \>17 years * written informed consent * chronic end-stage systolic heart failure with or without ventricular assist device * clinically stable for at least 6 weeks * prescription of cardiac rehabilitation exclusion criteria: * addictions or other illnesses that impact the ability to understand the nature, scope and consequences of the trial * lack of knowledge of german to fully understand study information * pregnancy, pre-menopausal women * participation in the rehabilitation program \< 80% * contraindications of cardiopulmonary exercise testing on an ergometer

Keywords: advanced heart failure ventricular assist device exercise training cardiac rehabilitation
evaluation of the interest of a video-assisted remote speech therapy consultation in patients with orl cancer (tele orthophonie)

Conditions: ORL Cancer

Summary: interventional, prospective, single-centre study aimed to evaluate the impact of a video-assisted remote speech therapy consultation in relation to the complexity and specificity of the care of patients with orl cancer. three indications will be studied: phonation problems, swallowing problems and other problems. the study will be conducted on a population of patients with t3, t4 orl cancer requiring speech therapy. each patient included will have a video-assisted speech therapy consultation with a private speech therapist and an expert speech therapist. at the end of this video consultation, the patient and the private speech therapist will be asked to complete a satisfaction questionnaire. at the follow-up visit following the video-assisted consultation, the patient will have completed participation in the study.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years at study entry. 2. patient with carcinological pathology of the vads, relevant to surgery and/or radiotherapy and/or chemotherapy. 3. patient managed at the iuct-o and by a private speech therapist (near the patient's home). 4. patient affiliated to a social security system in france. 5. patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure. exclusion criteria: 1. pregnant or lactating women. 2. any psychological, familial, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures foreseen in the study protocol. 3. patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).

Keywords: video-assisted speech therapy
tiv infant/toddler response evaluation - follow-up for influenza b boost

Conditions: Influenza

Summary: each winter, viruses belonging to two kinds of influenza a ("a/h1n1" \& "a/h3n2") and two kinds of influenza b ("b/yamagata" \& "b/victoria") can cause illness. the yearly influenza vaccine is designed to protect against both kinds of influenza a but only one or the other kind of influenza b. current recommendations in canada are that if an eligible child less than nine years of age has received two doses of influenza vaccine before, then that child only requires a single dose of influenza vaccine in subsequent years of immunization. in a previous study conducted in early 2010 we measured the antibody response to influenza b in children who had previously received two doses of a b/yamagata kind of virus contained in the 2008-09 influenza vaccine and just one dose of the b/victoria kind of virus contained in the 2009-10 recommended vaccine. the purpose of this follow-up study is to see if the protection (antibodies in the blood) provided against the influenza b/victoria kind of virus that was in the 2009-10 vaccine can be improved with another (second) dose of the same b/victoria kind of virus included in the 2010-11 vaccine. since influenza b is an illness especially of children, understanding how to best protect children against both kinds of influenza b is important.


Eligibility criteria:
inclusion criteria: * child previously participated in the titre ii study; * child is healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination; * child is available and can complete all relevant procedures during the study period; * parent or legal guardian is available and can be reached by phone during the study period; * parent/guardian provides written informed consent; * and, parent/guardian is fluent in english/french. exclusion criteria: * child has already received the 2010-11 seasonal (tiv) influenza vaccine * child has received immune globulin or other blood products within the prior six weeks; * child has received injected or oral steroids within prior six weeks; * child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period; * or, child has a recently acquired health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child.

Keywords: influenza vaccines infant dose-response relationship, immunologic prime-boost response
effects of myofascial massage and patient-therapist communication levels on shoulder muscle properties in breast cancer survivors with myofascial pain

Conditions: Pain, Myofacial

Summary: the objective of the proposed study is to assess how myofascial massage alters stiffness and microvascular perfusion of shoulder muscles and how these changes are influenced by patient-therapist interactions. the primary hypothesis is that stiffness of shoulder muscles will be decreased, and microvascular perfusion will be increased after a 30-minute myofascial massage, and that the addition of patient-therapist communication levels will result in greater changes with certain levels.

please note that there are certain details left off of this registration in order to collect information regarding certain aspects of the trial. these details (approved by the irb) will be updated at the end of the trial.

Eligibility criteria:
inclusion criteria: * previous unilateral breast cancer diagnosis * treatment for primary breast cancer was completed 3 months to 2 years prior to enrollment (defined as completion of all treatments except oral maintenance therapies) * myofascial pain in upper quadrant of the chest * ability to understand and willingness to sign a written informed consent. exclusion criteria: * chronic neuromuscular or orthopedic injury currently affecting upper extremity function that is unrelated to their cancer diagnosis * currently undergoing physical therapy, occupational therapy or other treatment for side effects related to their cancer diagnosis or other injury to the upper extremity * history of fibromyalgia * broken or bruised skin in the chest/shoulder area * diagnosed with metastatic breast cancer * currently receiving treatment for other forms of cancer

Keywords: massage therapy ultrasound history of unilateral breast cancer
prospective evaluation of an hydrophilic acrylic intraocular lens

Conditions: Cataract Senile

Summary: evaluation of the clinical safety and effectiveness of an hydrophilic acrylic intraocular lens

to show safety and the effectiveness in regard to the monocular corrected distance visual acuity (cdva) and the distance-corrected near visual acuity (dcnva) at 6 months postoperative.

Eligibility criteria:
inclusion criteria: 1. patients of any gender, aged 18 years or older 2. patient is planned for aged-related cataract surgery and implantation of the study iol into the capsular bag in at least one eye 3. patient is willing and capable of providing informed consent 4. patient is willing and capable of complying with visits and procedures as defined by this protocol exclusion criteria: 1. preoperative corrected distance visual acuity (cdva) better than 0.3 logmar (0.5 decimal) 2. endothelial cell count of less than 2000/mm2 3. ocular disorder that could potentially cause a clinically significant future visual acuity loss 4. preoperative corneal astigmatism ative corneal to be \< 1 d. 5. clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.) 6. clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies) 7. any clinically significant condition that could affect iol stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.) 8. any history of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis 9. any acute infection (acute ocular disease, external/internal infection, systemic infection) 10. any previous intraocular and corneal surgery 11. uncontrolled glaucoma or iop higher than 24mmhg under ocular hypertension treatment 12. current systemic or ocular pharmacotherapy that effects patients'vision 13. current pathology or condition that could be a risk for the patient according to the investigator opinion 14. women during pregnancy and/or lactation 15. patients unable to meet the limitations of the protocol or likely of noncooperation during the trial 16. patients whose freedom is impaired by administrative or legal order 17. subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients'vision
anti-inflammatory effects of simvastatin

Conditions: Inflammation; Atherosclerosis; Hypercholesterolemia

Summary: the purpose of this research study is to determine which of the two ingredients of vytorin (simvastatin or ezetimibe) is responsible for the anti-inflammatory effects of vytorin

cardiovascular disease is currently the leading cause of death in the developed countries. atherosclerosis is the most important cause of cardiovascular disease. statins are known to exert a powerful anti-atherogenic action which is reflected in a marked beneficial effect on the prevention of cardiovascular effects and cardiovascular mortality. they induce a reduction in the progression and an increase in the regression of atherosclerotic lesions. statins exert powerful effect on lowering ldlc and are also anti-inflammatory due to their ability to lower crp concentrations. but little is known about their anti-inflammatory effects at a cellular and molecular levels in humans, in vivo. vytorin, a preparation containing simvastatin and ezetimibe, has a powerful effect on lowering ldlc concentration through a combination of effects on the absorption of cholesterol from the gut and hepatic cholesterol biosynthesis. in our previous study we have shown that vytorin exerts a potent anti-inflammatory effect in the obese in the fasting state and following acute inflammatory changes induced by the intake of cream. the improve-it trial, which examined the benefits of adding ezetimibe to simvastatin, showed a small additional benefit of ezetimibe (a 6% reduction in cardiovascular events) compared to simvastatin alone. this is marginal when compared to the established cardiovascular benefits of statins. we, therefore, explore further into the anti-inflammatory actions of the two components of vytorin by comparing the effects of simvastatin versus ezetimibe on intracellular lipid and inflammation in obese patients to determine which of the two ingredients of vytorin is responsible for the specific combination of these effects.

Eligibility criteria:
inclusion criteria: 1. age: 18 to 75 years of age. 2. obese (bmi ≥30 kg/m2) 3. ldl cholesterol of ≥100 mg/dl 4. not taking any vitamins or antioxidants exclusion criteria: 1. currently using anti-hyperlipidemic therapies 2. triglycerides \>500 mg/dl. 3. myocardial infarction, angioplasty/stent placement or coronary artery bypass surgery in the past 6 months. 4. patient on chronic use of non-steroidal anti-inflammatory drugs or steroids 5. hepatic disease 6. renal impairment. 7. history of drug or alcohol abuse 8. participation in any other concurrent clinical trial 9. use of an investigational agent or therapeutic regimen within 30 days of study. 10. smoker 11. pregnancy 12. premenopausal women who are not on birth control pills and have not had a hysterectomy or tubal ligation 13. anemia with hemoglobin \<12 g/dl
managing urinary incontinence in elderly village women in rural bangladesh

Conditions: Urinary Incontinence

Summary: an intervention consisting of group and home based exercise will be used over 6 months to assess whether this is helpful in managing urinary incontinence in elderly village women in bangladesh. this intervention, supplemented by education about managing incontinence, will be used in half the villages in the trial. in the other half women will receive only the education component.

this is a cluster randomized trial in which all women aged 60-75 years reporting symptoms of urinary incontinence are randomly assigned, by village of residence, to either exercise plus education of to education alone.

Eligibility criteria:
inclusion criteria: * women aged 60-75 years reporting incontinence on a screening questionnaire (yes to questions 2,3or 4 on the 6 item urinary distress index) exclusion criteria: * they report a uterine prolapse which is (or becomes) known to be of 3rd degree or higher. * they are assessed by the village paramedic to be incapable of standing from sitting without help from someone else. * they are assessed by the village paramedic to be unable to walk without help at a normal pace for someone of her age. * they are assessed by the village paramedic as not having the intellectual capacity to understand questions and follow instructions.
composite tissue allotransplantation of the face: anatomical and functional evaluation

Conditions: Surgery, Oral

Summary: in hindsight, the first "face graft" raises the fundamental problem of composite tissue allotransplantation (hand, larynx, abdominal wall, etc.) with the addition of specific technical and philosophical problems. by proposing a prospective study concerning five new patients over the next three years, in the light of this first experience, the authors would like to confirm the surgical feasibility of this type of procedure, possibly extending it to other parts of the face (lateral third) and, like english and american teams, considering the possibility of total facial surface reconstruction. in parallel, and while complying with the usual immunosuppression procedures, the deliberate choice of creating a microchimerism by the infusion of bone marrow stem cells (the origin and quantity of which will need to be determined) will be reaffirmed, in order to improve mucocutaneous tissue tolerance, while confirming the safety of this type of approach. five new cases will also provide observations for the many new fields of research developing around composite tissue transplants (neurophysiology, skin histopathology, psychiatry, haematology, immunology, etc.).


Eligibility criteria:
inclusion criteria: * patients with loss of unrepairable substance by conventional techniques shreds, at the front exclusion criteria: * facial lesions repaired by conventional reconstructive surgery techniques * history of malignancy in remission for less than 5 years * malignant neoplasm undergoing changes * severe psychiatric history * patients above a score of 2 on the scale of the asa (american society of anesthesiology) * patients above a grade 1 in the classification nyha ( new york heart association ) * insufficient with renal creatinine clearance less than 70 ml / min or presence of a proteinuria * severe hypertension

Keywords: maxillofacial surgery face graft composite tissue stem cell infusion allotransplantation microsurgery
phase i study of hrs-3738 in recurrent and refractory non-hodgkin's lymphoma and multiple myeloma

Conditions: Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma

Summary: this study is an open-label, multicenter phase i clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of hrs-3738 in patients with recurrent and refractory non-hodgkin's lymphoma and multiple myeloma.


Eligibility criteria:
inclusion criteria: 1. active multiple myeloma in accordance with imwg criteria，or histopathologically and immunohistochemically confirmed non-hodgkin's lymphoma in accordance with the 2016 who classification of lymphoid neoplasias. 2. recurred or did not alleviate after the previous treatment. 3. have at least one measurable lesion. 4. with a life expectancy of ≥3 months. 5. male or female ≥ 18 years old. 6. ecog performance status of 0-1. 7. subjects must voluntarily agree to participate in the trial and sign a written informed consent form. exclusion criteria: 1. amyloidosis, plasma cell leukemia. 2. corrected serum calcium\>3.4mmol/l(13.5mg/dl). 3. presence of metastasis to central nervous system. 4. treatment of other investigational products. 5. major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study. 6. known history of hypersensitivity to any components of hrs-3738. 7. other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
comparative trial to investigate the efficacy and safety of desmopressin for the treatment of nocturia in adult women

Conditions: Nocturia

Summary: the purpose of the study is to investigate the efficacy and safety of two different dose levels of desmopressin orally disintegrating tablets against placebo for the treatment of nocturia in adult women during 12 weeks treatment


Eligibility criteria:
inclusion criteria: * has given written consent prior to any trial-related activity is performed. * female sex, aged 20 years or older. * at least 2 nocturnal voids every night in a consecutive 3-day period as documented in the diary during the screening period. * has given agreement about contraception during the trial. exclusion criteria: * showing symptoms of any of the following diseases: interstitial cystitis; overactive bladder, defined as \>6 daytime voids,≥1 urgency episode and ≥1 urge urinary incontinence episode per 24 hours as documented in the 3-day diary period; severe stress urinary incontinence. * psychogenic or habitual polydipsia. * urinary retention or a post void residual volume in excess of 150 ml as confirmed by bladder ultrasound performed after suspicion of urinary retention. * cancer. * a history of urologic malignancies or a history of cancer which has not been in remission for the last 5 years. * genito-urinary tract pathology. * neurogenic detrusor activity. * suspicion or evidence of heart failure. * uncontrolled hypertension. * uncontrolled diabetes mellitus. * hepatobiliary diseases: aspartate aminotransferase \>80 u/l or alanine aminotransferase \>90 u/l; total bilirubin \>1.5 mg/dl. * renal insufficiency: serum creatinine level \>0.82 mg/dl; estimated glomerular filtration rate \<50 ml/min. * hyponatraemia: serum sodium level \<135 meq/l. * central or nephrogenic diabetes insipidus. * syndrome of inappropriate antidiuretic hormone. * obstructive sleep apnea. * previous desmopressin treatment. * treatment with another investigational product within the past 3 months. * concomitant treatment with any prohibited medication. * pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial. * alcohol or substance abuse. * a job or lifestyle that may interfere with regular night-time sleep. * a mental condition, lack of decision-making ability, dementia, a speech handicap, or any other reason which, in the judgement of the investigator (sub-investigator), would impair the participation in the trial.